Covidien HawkOne Instrucciones De Uso página 5

guidance and manufacturer's declaration – electromagnetic emissions
The cutter driver is intended for use in the electromagnetic environment specified below. The customer or the
user of the cutter driver should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment guidance
RF emissions CISPR 11 Class B Group 1 The cutter driver is suitable for use in a typical hospital environment.
guidance and manufacturer's declaration – electromagnetic immunity
The cutter driver is intended for use in the electromagnetic environment specified below. The customer or the
user of the cutter driver should assure that it is used in such an environment.
Immunity test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment guidance
Electrostatic discharge ± 6 kV contact ± 6 kV contact
(ESD) ± 8 kV air ± 8 kV air
IEC 61000-4-2
Power frequency (50/60 Hz) 3 A/m 3 A/m
magnetic field
IEC 61000-4-8
Radiated RF 3 V/m 80 MHz to 3 V/m
IEC 61000-4-3 2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz
to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference
if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the
formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.
c) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location in which the Covidien cutter driver is used exceeds the applicable RF compliance
level above, the System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the cutter driver.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications
equipment and the Covidien cutter driver
The cutter driver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Covidien cutter driver can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the System.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter
W
150 kHz to 80 MHz
0.01 0.12 m
0.1 0.37 m
1 1.17 m
10 3.70 m
100 11.70 m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
ABOUT THIS MANUAL
Please read this manual and follow its instructions carefully. The words WARNING, CAUTION and NOTE
convey special meanings. When they are used throughout this manual, they should be carefully reviewed
to ensure the safe and effective operation of this product.
WARNINg: A WARNING indicates that the personal safety of the patient or physician may be involved.
Disregarding a WARNING could result in injury to the patient or physician.
CAUTION: A CAUTION indicates that particular service procedures or precautions must be followed to
avoid possible damage to the product.
NOTE: A NOTE indicates special information to facilitate use of the product, or to clarify important
information.
WARRANTY
Although this product has been manufactured under carefully controlled conditions, Covidien has no
control over the conditions under which this product is used. Covidien therefore disclaims all warranties,
both express and implied, with respect to the product including, but not limited to, any implied warranty
of merchantability or fitness for a particular purpose. Covidien shall not be liable to any person or entity
for any medical expenses or any direct, incidental or consequential damages caused by any use, defect,
failure or malfunction of the product, whether a claim for such damages is based upon warranty, contract,
tort or otherwise. No person has any authority to bind Covidien to any representation or warranty with
respect to the product.
The exclusions and limitations set out above are not intended to, and should not be construed so as to
contravene mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is
held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the
validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and
obligations shall be construed and enforced as if this Disclaimer of Warranty did not contain the particular
part or term held to be invalid.
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic mate-
rial, the relative humidity should be at
least 30%.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical hospital environment.
Portable and mobile RF communications
equipment should be used no closer to any
part of the cutter driver, than the recom-
mended separation distance calculated from
the equation applicable to the frequency of
the transmitter. The recommended separa-
tion distance is a minimum of 0.2 meter for
transmitters of 80 MHz to 2.5 GHz Interfer-
ence may occur in the vicinity of equipment
marked with the following symbol:
m
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.12 m 0.23 m
0.37 m 0.74 m
1.17 m 2.3 m
3.70 m 7.4 m
11.70 m 23.3 m
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